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Application A1006 – Food Derived from Herbicide tolerant soybean line DP-356043-5 – First Assessment Report

1 May 2009

Dear Sir/Madam

Thank you for the opportunity to comment on this application. The New Zealand Food Safety Authority (NZFSA) has had the Safety Assessment reviewed by the Institute of Environmental Science and Research (ESR) and has the following comments to make.

Characterisation of metabolites

As stated in section 5.6 ‘Characterisation of Metabolites’ of the First Assessment Report (FAR), the expression of the GAT4601enzyme has resulted in a significant increase in the levels of N-acetylated aspartate (NAAsp) and N-acetylated glutamate (NAGlu) when compared to levels in the parental soybean line and to reference ranges for soybean. It is concluded that because these two acetylated amino acids are typical constituents of the human diet, they do not raise any safety concerns. The data presented in the FAR shows that the levels of NAAsp and NAGlu in soybean line DP-356043-5 are significantly higher than the levels in common foods, on a per fresh weight basis. The only exception is the level of NAGlu in autolysed yeast, however, soy based food products are likely to be consumed in much greater quantities than autolysed yeast by some members of the population. From a dietary perspective, the increased level of NAAsp and NAGlu in soybean line DP-356043-5 may be significant. NZFSA and ESR consider that the FAR would be strengthened by providing data showing any common foods that contain these acetylated amino acids at levels comparable or close to those found in soybean line DP-356043-5, and consumed at comparable levels.

Hazard Assessment of Glyphosate Residues:

Two novel residues are generated on soybean DP-356043-5 plants following the application of glyphosate. These are N-acetyl glyphosate (NAG) and N-acetyl aminomethylphosphonic acid (N-acetyl AMPA).

The FAR considers whether the existing residue definition for glyphosate in soybean needs to be amended, for safety assessment purposes, to include NAG and N-acetyl AMPA. It is concluded that for the purpose of imported GM soy, the current Codex residue definition for glyphosate remains appropriate for safety assessment purposes. NZFSA agrees with this conclusion, as NAG and N-acetyl AMPA are not toxicologically significant. However, we note the proposed approach in section 6.1 of the FAR. NZFSA agrees that discussions should be held between the Australian Pesticides and Veterinary Medicines Authority (APVMA), FSANZ and NZFSA on any MRL issues arising from this application.

Yours sincerely